The Condensed List contains products that have at least one patent with compound, composition or "new polymorph, salt or hydrate" claims.
Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.
NAVELBINE (Injectable) VINORELBINE TARTRATE [GENERIC AP]
Drug Classes: ANTINEOPLASTICS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020388 Prod. No.: 001 RX (EQ 10MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4307100 [Extended 1053 days (2.9 years)] Nor bis-indole compounds usable as medicaments Claim Types: Compound; Composition; Method of use | Jan 8, 2003 *PED |
SEMPREX-D (Capsule) ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: COLD REMEDIES
NDA Applicant: CELLTECH PHARMS NDA No.: 019806 Prod. No.: 001 RX (8MG;60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4501893 3-{6-[3-Pyrrolidino-1-(4-tolyl)prop-1-enyl]-2-pyridyl}acrylic acid and pharmaceutically acceptable salts thereof Claim Types: Compound | Feb 1, 2003 | |
| Pat. No. 4650807 [Extended 1469 days (4 years)] Antihistaminic compositions and methods containing pyridine derivatives Claim Types: Composition; Method of use | Mar 26, 2008 | U-93: Use as an antihistamine/ decongestant |
REV-EYES (Solution/Drops) DAPIPRAZOLE HYDROCHLORIDE
Drug Classes: PHARMACEUTICAL AIDS; OPHTHALMICS, MISCELLANEOUS; CYCLOPLEGICS/MYDRIATICS
NDA Applicant: ANGELINI NDA No.: 019849 Prod. No.: 001 RX (0.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4252721 [Extended 1411 days (3.9 years)] Cycloalkyltriazoles and process for obtaining same Claim Types: Compound | Feb 7, 2003 |
NOLVADEX (Tablet) TAMOXIFEN CITRATE [GENERIC AB]
Drug Classes: ANTINEOPLASTICS; HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: ASTRAZENECA NDA No.: 017970 Prod. No.: 001 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4536516 Alkene derivatives Claim Types: Compound; Method of use | Feb 20, 2003 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 01,2006 PED | M-20: Labeling revisions related to McCune Albright Syndrome |
NOLVADEX (Tablet) TAMOXIFEN CITRATE [GENERIC AB]
Drug Classes: ANTINEOPLASTICS; HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: ASTRAZENECA NDA No.: 017970 Prod. No.: 002 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4536516 Alkene derivatives Claim Types: Compound; Method of use | Feb 20, 2003 *PED |
EVISTA (Tablet) RALOXIFENE HYDROCHLORIDE
Drug Classes: ESTROGENS/PROGESTINS
NDA Applicant: LILLY NDA No.: 020815 Prod. No.: 001 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4418068 Antiestrogenic and antiandrugenic benzothiophenes Claim Types: Compound; Composition; Method of use | Apr 3, 2003 | |
| Pat. No. 5393763 Methods for inhibiting bone loss Claim Types: Method of use | Jul 28, 2012 | U-114: Use for inhibiting bone resorption |
| Pat. No. 5457117 Method for inhibiting bone loss using 6-hydroxy-2-(4-hydroxyphenyl)-benzo[B][2-(piperidin-1-yl) ethoxyphenylimethanone hydrochloride Claim Types: Method of use | Jul 28, 2012 | U-114: Use for inhibiting bone resorption |
| Pat. No. 5478847 Methods of use for inhibiting bone loss and lowering serum cholesterol Claim Types: Method of use | Mar 2, 2014 | U-114: Use for inhibiting bone resorption |
| Pat. No. 5811120 Solid orally administerable raloxifene hydrochloride pharmaceutical formulation Claim Types: Formulation | Mar 2, 2014 | |
| Pat. No. 5972383 Solid orally administerable raloxifene hydrochloride pharmaceutical formulation Claim Types: Method of use | Mar 2, 2014 | U-287: Treatment or prevention of osteoporosis |
| Pat. No. 6458811 Benzothiophenes formulations containing same and methods Claim Types: Formulation; Method of use | Mar 10, 2017 |
ACCUPRIL (Tablet) QUINAPRIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ACE INHIBITORS
NDA Applicant: PFIZER PHARMS NDA No.: 019885 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE); 004 RX (EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4344949 [Extended 2 years] Substituted acyl derivatives of 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acids Claim Types: Compound; Composition; Method of use | Apr 3, 2003 *PED | U-3: Treatment of hypertension |
| Pat. No. 5747504 Method of treating cardiac insufficiency using angiotensin-converting enzyme inhibitors Claim Types: Method of use | Oct 10, 2005 *PED | U-210: Method of treating congestive heart failure |
| Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process | Aug 24, 2007 *PED | |
| Pat. No. 5684016 Method of treating cardiac insufficiency Claim Types: Method of use | May 4, 2015 *PED | U-210: Method of treating congestive heart failure |
ACCURETIC (Tablet) HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Drug Classes: ANTIHYPERTENSIVES; DIURETICS; ACE INHIBITORS
NDA Applicant: PFIZER PHARMS NDA No.: 020125 Prod. No.: 001 RX (12.5MG;EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4344949 [Extended 2 years] Substituted acyl derivatives of 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acids Claim Types: Compound; Composition; Method of use | Apr 3, 2003 *PED | U-3: Treatment of hypertension |
| Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process | Aug 24, 2007 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | JUN 28,2003 PED |
ACCURETIC (Tablet) HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Drug Classes: ANTIHYPERTENSIVES; DIURETICS; ACE INHIBITORS
NDA Applicant: PFIZER PHARMS NDA No.: 020125 Prod. No.: 002 RX (12.5MG;EQ 20MG BASE); 003 RX (25MG;EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4344949 [Extended 2 years] Substituted acyl derivatives of 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acids Claim Types: Compound; Composition; Method of use | Apr 3, 2003 *PED | U-3: Treatment of hypertension |
| Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process | Aug 24, 2007 *PED |
CEREBYX (Injectable) FOSPHENYTOIN SODIUM
Drug Classes: EXTRAPYRAMIDAL MOVEMENT DISORDERS; ANTICONVULSANTS
NDA Applicant: PARKE DAVIS NDA No.: 020450 Prod. No.: 001 RX (EQ 50MG PHENYTOIN NA/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4260769 [Extended 5 years] 5,5-Diphenylhydantoins Claim Types: Compound | Apr 7, 2003 | |
| Pat. No. 4925860 Stable pharmaceutical composition of 3-(hydroxymethyl)-5,5-diphenylhydantoin disodium phosphate ester Claim Types: Formulation; Method of use | Aug 5, 2007 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code ODE: Orphan Drug | AUG 05,2003 | For the acute treatment of patients with status epilepticus of the grand mal type. |
IOBENGUANE SULFATE I 131 (Injectable) IOBENGUANE SULFATE I 131
Drug Classes: DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE
NDA Applicant: CIS NDA No.: 020084 Prod. No.: 001 RX (2.3mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4584187 Imaging agent and method of use Claim Types: Compound; Method of use | Apr 22, 2003 |
MONOPRIL (Tablet) FOSINOPRIL SODIUM [GENERIC AB]
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 019915 Prod. No.: 002 RX (10MG); 003 RX (20MG); 004 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4337201 [Extended 2 years] Phosphinylalkanoyl substituted prolines Claim Types: Compound | Jun 4, 2003 *PED | |
| Pat. No. 5006344 Fosinopril tablet formulations Claim Types: Formulation | Jan 10, 2010 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Nov 27,2006 PED |
MONOPRIL-HCT (Tablet) FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Drug Classes: DIURETICS; ACE INHIBITORS
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 020286 Prod. No.: 001 RX (20MG;12.5MG); 002 RX (10MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4337201 [Extended 2 years] Phosphinylalkanoyl substituted prolines Claim Types: Compound | Jun 4, 2003 *PED | |
| Pat. No. 5006344 Fosinopril tablet formulations Claim Types: Formulation | Jan 10, 2010 *PED |
DECABID (Tablet, Extended Release) INDECAINIDE HYDROCHLORIDE
NDA Applicant: LILLY NDA No.: 019693 Prod. No.: 001 DISC (EQ 50MG BASE); 002 DISC (EQ 75MG BASE); 003 DISC (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4452745 [Extended 2 years] 9-Aminoalkylfluorenes Claim Types: Compound | Jun 5, 2003 |
CYTOVENE IV (Injectable) GANCICLOVIR SODIUM [GENERIC AP]
Drug Classes: ANTIVIRALS
NDA Applicant: ROCHE PALO NDA No.: 019661 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4355032 [Extended 763 days* (2.1 years)] 9-(1,3-Dihydroxy-2-propoxymethyl)guanine as antiviral agent Claim Types: Compound; Composition; Method of use | Jun 23, 2003 | U-64: Treatment of viral infections |
CYTOVENE (Capsule) GANCICLOVIR [GENERIC AB]
Drug Classes: ANTIVIRALS
NDA Applicant: ROCHE PALO NDA No.: 020460 Prod. No.: 001 RX (250MG); 002 RX (500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4355032 [Extended 763 days* (2.1 years)] 9-(1,3-Dihydroxy-2-propoxymethyl)guanine as antiviral agent Claim Types: Compound; Composition; Method of use | Jun 23, 2003 | U-64: Treatment of viral infections |
| Pat. No. 4642346 Anhydrous crystalline 9-(1,3-dihydroxy-2-propoxymethyl)guanine Claim Types: New polymorph, salt or hydrate | Jun 24, 2005 |
PLAVIX (Tablet) CLOPIDOGREL BISULFATE
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: SANOFI SYNTHELABO NDA No.: 020839 Prod. No.: 001 RX (EQ 75MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4529596 Thieno [3,2-c] pyridine derivatives and their therapeutic application Claim Types: Compound; Formulation; Method of use | Jul 5, 2003 | |
| Pat. No. 4847265 [Extended 1374 days (3.8 years)] Dextro-rotatory enantiomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-acetate and the pharmaceutical compositions containing it Claim Types: Compound; Composition | Nov 17, 2011 | |
| Pat. No. 5576328 Method for the secondary prevention of ischemic events Claim Types: Method of use | Jan 31, 2014 | U-432: Reduction of atherosclerotic events (myocardial infarction, stroke, and vascular death) in patients with atherosclerosis documented by recent stroke, recent myocardial infarction, or established peripheral arterial disease |
| Pat. No. 6429210 Polymorphic clopidogrel hydrogenesulphate form Claim Types: New polymorph, salt or hydrate | Jun 10, 2019 | |
| Pat. No. 6504030 Polymorphic form of clopidogrel hydrogen sulphate Claim Types: Product-by-process; Process | Jun 10, 2019 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | FEB 27,2005 | I-349: Acute coronary syndrome |
ARIXTRA (Injectable) FONDAPARINUX SODIUM
NDA Applicant: FONDA BV NDA No.: 021345 Prod. No.: 001 RX (2.5MG/0.5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4818816 Process for the organic synthesis of oligosaccharides and derivatives thereof Claim Types: Process; Compound; Composition | Aug 19, 2003 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JUN 17,2006 | I-397: Extended prophylaxis in patients undergoing hip fracture surgery |
| Exclusivity Code: NCE - New chemical entity | DEC 07,2006 |
DYNACIRC (Capsule) ISRADIPINE
Drug Classes: CALCIUM CHANNEL BLOCKERS
NDA Applicant: RELIANT PHARMS NDA No.: 019546 Prod. No.: 001 RX (2.5MG); 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4466972 [Extended 2 years] Benzoxadiazoles and benzothiadiazoles, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Method of use | Aug 21, 2003 | U-3: Treatment of hypertension |
DYNACIRC CR (Tablet, Extended Release) ISRADIPINE
Drug Classes: CALCIUM CHANNEL BLOCKERS
NDA Applicant: RELIANT PHARMS NDA No.: 020336 Prod. No.: 001 RX (5MG); 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4466972 [Extended 2 years] Benzoxadiazoles and benzothiadiazoles, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Method of use | Aug 21, 2003 | U-3: Treatment of hypertension |
| Pat. No. 4783337 Osmotic system comprising plurality of members for dispensing drug Claim Types: Device; Method of administration | Sep 16, 2003 | U-3: Treatment of hypertension |
| Pat. No. 4946687 Dosage form for treating cardiovascular diseases Claim Types: Device | Aug 7, 2007 | |
| Pat. No. 4950486 Dosage form for treating cardiovascular diseases Claim Types: Formulation | Aug 21, 2007 | |
| Pat. No. 4816263 Dosage form for treating cardiovascular diseases comprising isradipine Claim Types: Method of use | Oct 2, 2007 | U-3: Treatment of hypertension |
| Pat. No. 5030456 Dosage form for treating cardiovascular diseases Claim Types: Formulation | Jul 9, 2008 |
FLUDARA (Injectable) FLUDARABINE PHOSPHATE [GENERIC AP]
Drug Classes: ANTINEOPLASTICS
NDA Applicant: BERLEX NDA No.: 020038 Prod. No.: 001 RX (50MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4357324 [Extended 2 years] Prodrug derivatives of 9.beta.-D-arabinofuranosyl-2-fluoroadenine Claim Types: Compound; Method of use | Aug 24, 2003 *PED |
FLOXIN (Tablet) OFLOXACIN [GENERIC AB]
Drug Classes: QUINOLONES/DERIVATIVES; ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: ORTHO MCNEIL PHARM NDA No.: 019735 Prod. No.: 001 RX (200MG); 002 RX (300MG); 003 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4382892 [Extended 2 years] Benzoxazine derivatives Claim Types: Compound | Sep 2, 2003 |
QUIXIN (Solution/Drops) LEVOFLOXACIN
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: SANTEN NDA No.: 021199 Prod. No.: 001 RX (0.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4382892 [Extended 2 years] Benzoxazine derivatives Claim Types: Compound | Sep 2, 2003 | |
| Pat. No. 4551456 Ophthalmic use of norfloxacin and related antibiotics Claim Types: Method of use | Nov 14, 2003 | |
| Pat. No. 5053407 [Extended 810 days (2.2 years)] Optically active pyridobenzoxazine derivatives and anti-microbial use Claim Types: Compound; Method of use | Dec 20, 2010 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | AUG 18,2003 |
RENORMAX (Tablet) SPIRAPRIL HYDROCHLORIDE
NDA Applicant: SCHERING NDA No.: 020240 Prod. No.: 001 DISC (3MG); 002 DISC (6MG); 003 DISC (12MG); 004 DISC (24MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4470972 [Extended 2 years] 7-Carboxyalkylaminoacyl-1,4-dithia-7-azaspiro[4.4]-nonane-8-carboxylic acids Claim Types: Compound; Composition; Method of use | Sep 11, 2003 | U-3: Treatment of hypertension |
SERZONE (Tablet) NEFAZODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIDEPRESSANTS
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 020152 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG); 004 RX (200MG); 005 RX (250MG) NDA No.: 020152 Prod. No.: 006 DISC (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4338317 [Extended 2 years] Phenoxyethyl-1,2,4,-triazol-3-one antidepressants Claim Types: Compound; Composition; Method of use | Sep 16, 2003 *PED |
CERETEC (Injectable) TECHNETIUM TC-99M EXAMETAZIME KIT
Drug Classes: DIAGNOSTICS - RADIOPHARMACEUTICALS; DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE; ANTIDOTES, SPECIFIC; PHARMACEUTICAL AIDS
NDA Applicant: AMERSHAM HLTH NDA No.: 019829 Prod. No.: 001 RX (N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4615876 Macrocyclic complexes of technetium-99m for use as diagnostic radionuclides Claim Types: Composition | Oct 7, 2003 | |
| Pat. No. 4789736 Complexes of technetium-99m with propylene amine oximes Claim Types: Formulation; Excipient | Dec 6, 2005 |
BREVIBLOC (Injectable) ESMOLOL HYDROCHLORIDE
Drug Classes: BETA BLOCKERS; ANTIARRHYTHMICS
NDA Applicant: BAXTER HLTHCARE CORP NDA No.: 019386 Prod. No.: 002 RX (250MG/ML) NDA No.: 019386 Prod. No.: 003 DISC (100MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4593119 Method for treatment or prophylaxis of cardiac disorders Claim Types: Compound | Dec 3, 2003 *PED | |
| Pat. No. 5017609 Pharmaceutical composition and method of treatment or prophylaxis of cardiac disorders Claim Types: Formulation; Process | Nov 21, 2008 *PED |
BREVIBLOC IN PLASTIC CONTAINER; BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER (Injectable) ESMOLOL HYDROCHLORIDE
Drug Classes: BETA BLOCKERS; ANTIARRHYTHMICS
NDA Applicant: BAXTER HLTHCARE CORP NDA No.: 019386 Prod. No.: 004 RX (1GM/100ML); 005 RX (2GM/100ML); 006 RX (10MG/ML); 007 RX (20MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4593119 Method for treatment or prophylaxis of cardiac disorders Claim Types: Compound | Dec 3, 2003 *PED | |
| Pat. No. 6310094 Ready-to-use esmolol solution Claim Types: Formulation; Process | Jul 12, 2021 *PED | |
| Pat. No. 6528540 Esmolol formulation Claim Types: Formulation; Process | Jul 12, 2021 *PED |
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Injectable) CIPROFLOXACIN
NDA Applicant: BAYER PHARMS NDA No.: 019858 Prod. No.: 001 DISC (200MG/100ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4670444 [Extended 3 years] 7-amino-1-cyclopropyl-4-oxo-1, 4-dihydro-quinoline-and naphthyridine-3-carboxylic acids and antibacterial agents containing these compounds Claim Types: Compound; Composition; Method of use Comments: Terminal Disclaimer that is not noted on the face of the patent resulted in the expiration date of Dec. 9, 2003 (see Bayer v. Carlsbad Technology (Fed. Cir., Aug. 14, 2002)). According to the PTO listing of extended patents, the 3-year extension of this patent applies to BAYTRIL (an animal antibiotic) rather than CIPRO. | Dec 9, 2003 | |
| Pat. No. 4705789 Solutions of lactic acid salts of piperazinylquinolone- and piperazinyl-azaquinolone-carboxylic acids Claim Types: Formulation | Nov 10, 2004 | |
| Pat. No. 4808583 Solutions of lactic acid salts of piperazinylquinolone- and piperazinyl-azaquinolone-carboxylic acids Claim Types: Formulation | Feb 28, 2006 | |
| Pat. No. 4957922 Infusion solutions of 1-cyclopropyl-6-fluoro-1,4-di-hydro-4-oxo- 7-(1-piperazinyl)-quinoline-3-carboxylic acid Claim Types: Formulation | Sep 18, 2007 |